Actively Recruiting
A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters with Chemotherapy for Locally Advanced and Metastatic Pancreatic Cancer
Led by Alpha Tau Medical LTD. · Updated on 2026-05-06
40
Participants Needed
15
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pancreatic cancer treatment by evaluating the safety and effectiveness of Alpha DaRT, a device that emits alpha radiation, combined with chemotherapy. The study focuses on patients with either locally advanced or metastatic pancreatic cancer. The main goal is to monitor safety by tracking device-related adverse events, while also assessing how well the treatment controls pain and supports survival. This research is conducted at multiple centers and includes two patient groups based on disease stage and chemotherapy type. Participants receive chemotherapy with either mFOLFIRINOX or Gemcitabine/Abraxane, depending on their group. During the first four cycles of chemotherapy, the Alpha DaRT device is placed directly into the tumor using an endoscopic procedure. The study has two cohorts: one for patients with locally advanced pancreatic cancer and another for those with metastatic disease. Follow-up assessments continue for up to six months after enrollment to evaluate outcomes. Throughout the study, participants undergo regular evaluations including safety monitoring for serious adverse events over a period of up to 24 months. Researchers will measure pain response at 30 days and two months after the procedure, and track the rate of surgical resection for locally advanced cases at six and 24 months. The study records overall and progression-free survival to assess treatment effectiveness, while monitoring participants' health status and laboratory tests to ensure safety during and after treatment.
CONDITIONS
Brief Title
Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) or metastatic pancreatic adenocarcinoma (Cohort 2).
- Starting treatment with mFOLFIRINOX (up to 4 cycles) before DaRT placement.
- Tumor lesion suitable for Alpha DaRT implantation.
- Measurable lesion per RECIST version 1.1 criteria.
- Lesion size 5 cm or less in longest diameter.
- Interstitial radiation indication confirmed by a multidisciplinary team.
- ECOG Performance Status 0 to 2.
- Life expectancy greater than 6 months.
- White blood cell count at least 3500/µl and granulocytes at least 1500/µl.
- Platelet count at least 60,000/µl.
- Creatinine 1.9 mg/dL or less.
- AST and ALT levels 2.5 times or less the upper limit of normal.
- INR less than 1.4 for patients not on Warfarin.
- Age 18 years or older.
- Ability and willingness to sign informed consent.
- Women of childbearing potential must have a negative pregnancy test before treatment and agree to use contraception for 3 months after Alpha DaRT therapy.
- All patients must agree to use adequate contraception during the study and for 3 months after DaRT insertion.
You will not qualify if you...
- For Cohort 1: Borderline unresectable pancreatic cancer or fit for surgery unless surgery is refused.
- Prior pancreatic cancer treatment except 1 to 4 cycles of mFOLFIRINOX.
- Known allergy to any treatment components.
- Use of systemic immunosuppressive therapy except brief corticosteroids.
- Significant cardiovascular disease such as severe heart failure, uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, hypertension, or recent heart attack.
- Uncontrolled illnesses including active infections or psychiatric/substance abuse disorders interfering with study participation.
- Active additional cancers requiring treatment except low-risk skin or prostate cancers.
- Need for treatments conflicting with this study's endpoints.
- Refusal to use contraception as required.
- Participation in another interventional study within 30 days that might interfere with this trial.
- High risk of not following the study protocol.
- Breastfeeding women or women unwilling to use contraception as required.
- High risk for radiation complications due to genetic, inflammatory bowel, or connective tissue diseases.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the first 4 chemotherapy cycles
Participants receive chemotherapy with mFOLFIRINOX or Gemcitabine/Abraxane and undergo placement of the Diffusing Alpha Radiation Emitters (DaRT) device during the first 4 cycles of chemotherapy.
Approximately 4 treatment visits during chemotherapy cycles
Duration - Up to 6 months after enrollment
Participants are monitored for safety and response to treatment for up to 6 months after enrollment.
Follow-up visits scheduled up to 6 months post-treatment
Trial Site Locations
Total: 15 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
City of Hope
Goodyear, Arizona, United States, 85338
Not Yet Recruiting
3
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
4
Cedars-Sinai
Los Angeles, California, United States, 90048
Not Yet Recruiting
5
Advent Health Cancer Institute
Orlando, Florida, United States, 32804
Not Yet Recruiting
6
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
7
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Actively Recruiting
8
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Lenox hill Hospital
New York, New York, United States, 10075
Not Yet Recruiting
10
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
11
Texas Oncology
Houston, Texas, United States, 75251
Not Yet Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77054
Not Yet Recruiting
13
University Cancer and Diagnostic
Houston, Texas, United States, 77089
Actively Recruiting
14
Jewish General Hospital
Montreal, Quebec, Canada
Not Yet Recruiting
15
Hadassah Ein Kerem
Jerusalem, Israel
Actively Recruiting
Research Team
L
Liron Dimnik
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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